Improving MEDication Adherence in Chronic Heart Failure Using a TELEmedicine Device (TELEMED-HF)
TELEMED-HF is a randomized, controlled clinical intervention trial designed to: (1) examine the efficacy of an electronic Medication Adherence Support System (MASS) in improving and monitoring patients' medication adherence; to (2) i determine the effect of medication adherence on hospitalization and health care consumption.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Randomized, Controlled Trial Using a TELEmedicine Solution to Improve MEDication Adherence in Chronic Heart Failure (TELEMED-HF)|
- Change in medication adherence [ Time Frame: Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months ] [ Designated as safety issue: No ]Objective medication adherence will be assessed using the MASS monitor output collected in a web-based application and the refill rates provided by the patients' pharmacies.
- Change in number of hospitalizations (costs) [ Time Frame: Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months ] [ Designated as safety issue: No ]A cost-benefit analysis will be assessed by means of the TiC-P questionnaire and event rate (and related DBC (diagnosis treatment combination, the Dutch system to allocate costs to treatments of specific patient groups)). The TiC-P questionnaire will enable us to compare healthcare consumption in the intervention and control group.
- Change in self-care behavior and Quality of Life [ Time Frame: Baseline, 6 months, 12 months, and 18 months ] [ Designated as safety issue: No ]
- Course of disease severity [ Time Frame: Baseline, 6 months, 12 months, and 18 months ] [ Designated as safety issue: No ]Clinical characteristics (e.g. NYHA function class determination, LVEF, exercise capacity, blood tests) and self-reported HF symptoms
- Change in psychological variables [ Time Frame: Baseline, 6 months, 12 months, and 18 months ] [ Designated as safety issue: No ]Type D personality, depression, anxiety
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
|Experimental: TELEmonitoring intervention||
Behavioral: Medication Adherence Support System (MASS)
The intervention consists of the use of an electronic Medication Adherence Monitor for a 6-month period as well as 2 visits to the heart failure outpatient clinic of the TweeSteden hospital (usual care). This monitor (a) dispenses all prescribed medication in the right dosage at the specified time, (b) reminds patients to take their medications through an alarm, sms or voicemail service and records adherence, and (c) sends critical data about non-adherence to the heart failure nurse, via a web application (CarebyWeb). The Medication Adherence Monitor is provided to the patient by the hospital pharmacy, including an instruction how to use the device. After the intervention patients return to usual care only. We expect a training effect, with continued improved adherence in the intervention group.
Other Name: PICO® by Vitaphone Nederland BV
|No Intervention: Usual care|
|Tilburg, Noord-Brabant, Netherlands, 5042AD|
|Principal Investigator:||Nina Kupper||Tilburg University, The Netherlands|